Cognitive and Emotional Skills to Aid Smoking Prevention

NCT03058991 | Completed Results

• 2 other identifiers: 1R21DA041531-01R21DA041531
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current proposal is to investigate the extent to which interventions designed to improve cognitive (working memory) and emotional (distress tolerance) regulatory processes enhance the effectiveness of standard no-smoking informational interventions. Emotional and cognitive dysregulation increases the likelihood of smoking and makes it particularly challenging to benefit from standard interventions. Working memory and associated deficits make it more difficult for individuals to utilize information from interventions, make judicious decisions regarding the cost and benefits of smoking, and to resist targeted advertising. In addition, disruptions in emotion regulatory capacities increase the probability of using cigarettes as a coping mechanism to self-regulate negative affect and stress. Individuals with affective disturbances smoke at higher rates and have more difficulties quitting, and are more likely to smoke as a way to reduce negative affect. The goal of the current project is to generate new insights and new approaches to smoking prevention among low-SES youth by investigating (1) the influence of known SES-related deficits in working memory and affect regulation on proximal measures of smoking risk, and (2) the potential for targeted interventions to reverse these risks. Specifically, the investigators examine the influence of working memory training and distress tolerance (mindfulness) interventions on cognitive/affective targets placing individuals at risk for smoking initiation and maintenance. The specific aims of this study are therefore to investigate:

1. 1.The feasibility and acceptability of school- and community-based brief interventions targeting working memory and distress tolerance in a diverse sample of low SES adolescents.
2. 2.The effects of working memory and distress tolerance interventions, relative to a standard informational intervention alone, on specific cognitive-affective targets-delay discounting and distress tolerance--relevant to cigarette smoking initiation and maintenance.
3. 3.The impact of cognitive /affective target activation on proximal measures of smoking risk/behavior and related health outcomes following intervention.

Conditions

Tobacco Smoking

Outcome Measures

Primary Outcomes (7)

• Specific Aim 1: Percentage of Participants Who Attended 13 or More Interventions

  Feasibility/acceptability of each intervention (indexed by attendance of at least 80% of interventions by 70% of the randomized sample) will be assessed.

  Intervention (week 1 to week 8)

• Specific Aim 2: Working Memory Capacity

  Assessment includes three computer-administered WM performance measures (N-back, Auditory Digit Span, and Corsi Block Tapping task) which are z-scored and aggregated to create a single WM index.The Working Memory Capacity Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population and higher scores reflecting greater capacity.

  1 Week

• Specific Aim 2: Distress Tolerance

  Distress Tolerance (DT) assessment includes the Distress Intolerance Index (DII) and the computerized Mirror-Tracing Persistence Task (MTPT-C) which are z-scored and aggregated to form a single DT index.The Distress Tolerance Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population and with higher scores reflecting worse tolerance.

  1 Week

• Specific Aim 3: Smoking Risk (Standard Smoking Assessment)

  The Standard Smoking Assessment is one of 3 assessments of smoking risk along with the B-IAT and the Delay Discounting task. Reported here are the results from the SSA, a 5-item scale asking about attitudes and likelihood of smoking with total scores ranging from 0 (no susceptibility) to 11 (highest susceptibility). The natural log of these scores are reported, with higher scores indicating higher susceptibility.

  1 Week

• Specific Aim 3: Smoking Risk (B-IAT)

  The brief Implicit Attitudes Test is one of 3 assessments of smoking risk along with the Delay Discounting task and the SSA. Reported here are the d-scores from the B-IAT task. Participants sorted stimuli into "positive" or "negative" categories in 4 blocks--2 of which included "Smoking" and "I feel positive," the other 2 including "Smoking" and "I feel negative." Shorter response times when sorting "Smoking--Positive" versus "Smoking--Negative" blocks indicate implicit tendency to associate "smoking" with "positive." Standardized difference scores (d-scores) were computed using the improved scoring algorithm recommended by prior research (Greenwald, Banaji, \& Nosek, 2003). Higher d-scores indicate less positive implicit attitudes towards smoking.

  1 Week

• Specific Aim 3: Smoking Risk (Delay Discounting Task)

  The Delay Discounting task is one of 3 assessments of smoking risk along with the B-IAT and SSA. It includes a series of computerized decisions in which participants select a money award immediately or a larger award in 7, 14, or 30 days time. Participants were notified that they would be paid the amount selected on one randomly selected trial. K-values were submitted for analyses with higher scores representing great discounting of delayed rewards, meaning that higher scores reflect greater tendency to select the immediate award. Natural logs of K-values were used if K-values showed a large amount of skew. Reported here are the natural logs of k-values from the delay discounting task. Natural logs are used to reduce skew of k-values.

  1 Week

• Specific Aim 4: Actual Smoking Status

  The piCO Smokerlyzer is a tool used to assess amount of carbon monoxide exhaled by a participant, with scores ranging from 0 to 150 parts per million (PPM), with scores under 3 indicating non-smoking and scores over 36 indicating very heavy addiction. The Timeline Follow Back is a self-report measure in which participants report the amount of cigarettes smoked each day for the last month. Mean proportions of smokers are reported (0=no smoking, 1=smoking) with smoking behaviors assessed via the piCO Smokerlyzer and the Timeline Follow Back.

  1 Week

Study Arms (3)

Distress Tolerance Intervention

EXPERIMENTAL

For the Distress Tolerance Intervention, the investigators will use a Mindfulness Based Stress Reduction (MBSR) program that has been adapted for use with adolescents. This version of MBSR follows closely the original conceptualization developed by Kabat-Zinn. The focus is on formal and informal mindfulness practices, which encourage participants to foster intention, attention and attitude. The investigators will make slight modifications to the delivery of the MBSR intervention to take into account the developmental period of their participants (e.g., attention span) to encourage retention and increase relevancy. These changes will also allow the investigators to match the duration with their Working Memory Intervention.

Behavioral: Distress Tolerance Intervention

Working Memory Intervention

EXPERIMENTAL

For the working memory training, the investigators will use the Cogmed RM program. Participants will be asked to use the program, while supervised twice a week, each time for an hour, for 8 weeks. Participants will also be asked to use the program on the other days for 25-35 minutes. The program resembles a video game, and comprises several different "games" that require visuo-spatial working memory (remembering the position of objects) and a combination of verbal and visual working memory (remembering phonemes, letters, and digits). The program adapts to the user's performance, such that trainees are able to perform at the limit of their ability, stimulating WM capacity adaptation.

Behavioral: Working Memory Intervention

Control Informational Intervention

ACTIVE COMPARATOR

This Control Informational Intervention has been used in the investigators' and other's previous studies. In the current application, it will match the session time of the Distress Tolerance and Working Memory interventions and will omit a focus on smoking (which is specific to the SPII intervention provided across all interventions), and will consist of discussions of a variety of healthy lifestyle topics, such as healthy eating, stress/time management, and recommended health screenings.

Behavioral: Control Informational Intervention

Interventions

Distress Tolerance Intervention BEHAVIORAL

See arm/group description.

Distress Tolerance Intervention

Working Memory Intervention BEHAVIORAL

See arm/group description.

Working Memory Intervention

Control Informational Intervention BEHAVIORAL

See arm/group description.

Control Informational Intervention

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents (ages 12 years or older) enrolled in high school as a freshman or sophomore.
• Reflecting the demographics of the community in which we are recruiting, we expect approximately 70% of the sample to be at or below the poverty level, balanced between males and females, with the majority from an ethnic minority background.

You may not qualify if:

• Non-English speaking (operationalized as the inability to read and understand the consent form and converse in spoken English)

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Claremont McKenna College: collaborator
• Virginia Polytechnic Institute and State University: collaborator
• Southern Methodist University: collaborator
• University of Houston: collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Otto MW, Gorlin EI, Rosenfield D, Patten EA, Bickel WK, Zvolensky MJ, Doan SN. Rescuing cognitive and emotional regulatory skills to aid smoking prevention in at-risk youth: A randomized trial. Contemp Clin Trials. 2018 Jul;70:1-7. doi: 10.1016/j.cct.2018.04.005. Epub 2018 Apr 12.

  PMID: 29655859 BACKGROUND

• Otto MW, Rosenfield D, Gorlin EI, Hoyt DL, Patten EA, Bickel WK, Zvolensky MJ, Doan SN. Targeting cognitive and emotional regulatory skills for smoking prevention in low-SES youth: A randomized trial of mindfulness and working memory interventions. Addict Behav. 2020 May;104:106262. doi: 10.1016/j.addbeh.2019.106262. Epub 2019 Dec 24.

  PMID: 31918169 BACKGROUND

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Dr. Michael Otto
• Organization: Boston University Charles River Campus

mwotto@bu.edu

617-353-9610

Study Officials

• Michael W Otto, Ph.D.

  Boston University

  PRINCIPAL INVESTIGATOR

• Stacey Doan, Ph.D.

  Claremont McKenna College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: February 23, 2017
• Study Start: November 8, 2016
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: July 23, 2021
• Results First Posted: February 17, 2020

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)